NCT02210871已完成1 期
A Multi-centre, Open-label, Parallel-group Trial Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the semaglutide plasma concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age at least 18 years at the time of signing informed consent
- •Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
- •Only for subjects with hepatic impairment (mild, moderate and severe): A diagnosis of cirrhosis due to parenchymal liver disease, classified as Child-Pugh grade A,B or C as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy
- •Only for subjects with normal hepatic function: Subjects who are judged to be in good general health based on physical examination, medical history, ECG, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
- •Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
- •Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
- •Donation of any blood or plasma in the past month or in excess of 400 mL within the 3 months preceding screening, or surgery or trauma with more than 400 mL blood loss within the 3 months preceding screening
研究组 & 干预措施
Normal hepatic function
Experimental
干预措施: semaglutide (Drug)
Mild hepatic impairment
Experimental
干预措施: semaglutide (Drug)
Moderate hepatic impairment
Experimental
干预措施: semaglutide (Drug)
Severe hepatic impairment
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the semaglutide plasma concentration-time curve
时间窗: Day 1 - day 36
次要结局
- Maximum observed semaglutide plasma concentration(Day 1 - day 36)
- Number of treatment emergent adverse events (TEAEs)(Day 1 - day 36)
研究者
研究点 (1)
Loading locations...
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